MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MULTI HOLE WIRE GUIDE

Model Number	03.037.000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the multihole wire guide was not permeable to the guide wire during a practical workshop with the tfna team that was held in the office.There was no patient involvement.This report is for one (1) multi hole wire guide.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Corrected data: event date.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- shipped back device ¿multihole drill sleeve¿ with lot number l203835 is in used conditions.The device shows moderate scratches and the presence of signs of damage.In particular, on the tip of the central channel, the damaged material creates a small edge that narrows the diameter of the hole.The two external channels of the device passed functional test with guide wire 3.2, gauge 60078828, while the central one failed the test.Guide wire 3.2 was introduced in the central channel from the back of the device.It was able to pass through the entire central channel, but it stopped after it came out of the tip hole for few millimeters.All the documents mentioned above have been analyzed.The manufacturing process was executed according to the analyzed documents and no anomalies were found.According to evidences is not possible to address the final root cause to a manufacturing issue.Most likely the device was used incorrectly and the mishandling caused damage to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.Device history lot part: 03.037.000, lot: l203835, manufacturing site: hägendorf, release to warehouse date: 12.Jan.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MULTI HOLE WIRE GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8637367
• Report Number: 8030965-2019-64460
• Device Sequence Number: 2091691
• Product Code: FZX
• UDI-Device Identifier: 10886982070166
• UDI-Public: (01)10886982070166
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.037.000
• Device Catalogue Number: 03.037.000
• Device Lot Number: L203835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 05/28/2019; 06/28/2019; 07/17/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/24/2019; 07/15/2019; 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1